The purpose of this study is to see if the study drug, suvorexant, is safe and effective in treating symptoms of insomnia in people with Parkinson's Disease. It is anticipated that a total of 20 subjects, 30 to 80 years of age, with Parkinson's Disease and symptoms of insomnia will participate in the study at this site
The proposed study is a randomized, double-blind, placebo-controlled, cross-over trial to assess the safety, tolerability, and efficacy of suvorexant specifically in a cohort of 20 Parkinson's Disease patients between the ages of 30 and 80 (inclusive) who have a complaint of insomnia. After informed consent is given, potential subjects will be screened to ensure they meet eligibility criteria. This will include an overnight polysomnogram, which will serve both as a baseline and a screening polysomnogram. Active drug will be suvorexant 10 mg orally at bed time with an optional up-titration to 15 mg orally at bedtime after 2 weeks. The first treatment period will be 4 weeks long, in which subjects will be randomized 1:1 to receive active drug or matching placebo. At the end of treatment period 1, subjects will undergo efficacy assessment with repeat polysomnogram and clinical scales. This will be followed by a 2-week washout period with placebo; this period only will be single-blinded, as subjects only will be blinded to treatment. Subjects will then be crossed over into the alternate treatment group, which will once again be double-blinded; those on active treatment for period 1 will be switched to placebo, and those on placebo in period 1 will be switched to active treatment. Treatment period 2 will also be 4 weeks long, and at the end of this, subjects will undergo final assessment with polysomnogram and clinical scales.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
21
10 mg Suvorexant or matching Placebo orally at bedtime with optional up-titration to 15 mg Suvorexant or matching Placebo orally at bedtime after 2 weeks.
10 mg Suvorexant or matching Placebo orally at bedtime with optional up-titration to 15 mg Suvorexant or matching Placebo orally at bedtime after 2 weeks.
Evergreenhealth Booth Gardner Parkinsons Care Center
Kirkland, Washington, United States
Change in Sleep Efficiency as Measured by Polysomnogram
Sleep efficiency is defined as total sleep time divided by total time in bed, expressed as a percent. Polysomnograms were performed at baseline, end of treatment period 1, and end of treatment period 2. A positive change indicates improvement in sleep efficiency. Assessing difference between change in sleep efficiency during suvorexant period and change in sleep efficiency during placebo period.
Time frame: 4 weeks
Wakefulness After Sleep Onset (WASO)
Wakefulness after sleep onset (WASO) is defined as total time spent awake after first epoch of sleep and before final awakening. Captured during polysomnograms performed at baseline, end of treatment period 1, and end of treatment period 2. Measured in minutes. A negative change indicates improvement in WASO.
Time frame: 4 weeks
Latency to Persistent Sleep (LPS)
Latency to Persistent Sleep (LPS) is defined as total time between lights out and first epoch of sleep. Measured on polysomnogram performed at baseline, end of treatment period 1, and end of treatment period 2. A negative change indicates improvement in LPS.
Time frame: 4 weeks
Insomnia Severity Index (ISI)
The Insomnia Severity Index (ISI) is a 7-question survey assessing symptoms of insomnia. Scores range from 0 to 28, with higher scores indicating greater severity. Thus, a negative change in the ISI score indicates improvement in sleep. Performed at baseline, end of treatment period 1, start of treatment period 2, and end of treatment period 2.
Time frame: 4 weeks
Epworth Sleepiness Scale (ESS)
The Epworth Sleepiness Scale (ESS) is an 8-question survey assessing symptoms of daytime sleepiness. Scores range from 0 to 24, with higher scores indicating greater severity of daytime sleepiness. Thus, a negative change indicates improvement in daytime sleepiness. The ESS has been validated for use in the general population and in PD. Administered at start of treatment period 1, end of treatment period 1, start of treatment period 2, and end of treatment period 2.
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Time frame: 4 weeks
Subject's Global Impression of Change (SGI-C)
The Subject's Global Impression of Change (SGI-C) is a rating scale that asks a single question: "Since baseline (when first starting this study), how have your sleep symptoms changed?" Answers will be on a 7-point scale: 1 = much improved; 2 = somewhat improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = somewhat worse; and 7 = much worse. Evaluated at end of treatment period 1 and end of treatment period 2.
Time frame: 4 weeks
Clinician's Global Impression of Change (CGI-C)
The Clinician's Global Impression of Change (CGI-C) is a rating scale that asks the single question: "Since baseline (when first starting this study), how have the subject's sleep symptoms changed?" Answers will be on a 7-point scale: 1 = much improved; 2 = somewhat improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = somewhat worse; and 7 = much worse.
Time frame: 4 weeks